Supporting product development innovation besides having the manufacturing capabilities is something there is a lot of focus around. Around 70% of the new pharmaceuticals products launched in the Indian market are coming from the leading Indian contract development and manufacturing organization (CDMOs), so existing large pharma companies are outsourcing it to the Indian CDMOs.
The increasing outsourcing trend in the pharmaceutical industry demonstrates the success of this partnership, as CDMOs are increasingly becoming an integral part of their value chains. However, the COVID-19 pandemic has enhanced the position of the CDMOs across the world. Today, CDMOs have an opportunity to venture beyond the traditional model and establish themselves as vital partners and build strategic, integrated partnerships with their customers.
In an exclusive conversation with the Financial Express Online, Hitesh Windlass, Managing Director, Windlas Biotech talked about the evolving role of CDMOs in the pharmaceutical industry and the outsourcing trends. Excerpts:
Brief perspective on the CDMO sector in India vis-à-vis the global scenario
The contract development and manufacturing organization essentially caters to two ecosystems – i) The innovator/pharmaceutical companies – ones that are doing the research and bringing new products in the market and 2) Generic drug manufacturers – ones who focus on making the drugs accessible to patients at an affordable price.
The global ecosystem is reared more towards innovator pharma companies while the Indian market primarily consists of branded generics and trade generics (although trade generic is still growing). In India, the CDMOs mainly cater to the generic industry. The outsourcing market size for pharmaceutical manufacturing and development in India roughly stands at 20,000 crores and is expected to grow about 40,000 crores in next five years. There are Contract Manufacturing Organisations (CMOs) and CDMOs – in the former, contract manufacturers take the technology from the customer to develop the product and in the latter, contract development and manufacturing organizations develop their own Intellectual Property (IP) to meet the customer requirements. The market size is growing quite strongly because more and more large pharma companies in India are looking to outsource products which is one of the strongest drivers of growth of CDMOs in India.
CDMOs should review their R&D and manufacturing capacities, capabilities and strengths to identify the opportunities for differentiation. For instance, Windlas Biotech is collaborating large multinationals and Indian pharma companies across the world to bring innovative products to market. These innovations are focused on three themes – improving patient compliance, exploring novel drug delivery systems and reducing cost of therapy.
Founded in 2001, Windlas Biotech has a strong track record of partnering with large multinationals and Indian pharma companies to bring new products to the market. It provides approximately two billion dosages annually to patients suffering from cardiovascular, diabetes and other chronic ailments. Windlas branded products are also available across India and include prescription generics, over-the-counter and nutrition products. Windlas Biotech also has one patent to its credit and three more are in pipeline.
How are CDMOs of help in terms of accessibility and affordability of generic medicines?
The Government of India, through its initiatives like Ayushman Bharat and Jan Aushadhi Yojana has opened a channel for drug manufacturers to provide quality and affordable medicines to every village in the country. Over 76,000 health and wellness centres (HWC) have been set up by the Government with an emphasis on implementing modern health infrastructure across a network of hospitals and modern laboratories. CDMOs like Windlas Biotech are uniquely positioned to offer generic drugs at an affordable cost and at the same time are able to meet the quality requirements as well.
How can demand-supply gap be bridged?
The government has taken the necessary first step of bringing even the poorest of people under the umbrella of health insurance through Ayushman Bharat wherein more healthcare centres have been brought into smaller cities, government, hospitals, ESI hospitals. All of these are extremely important because they will bring the health care providers closer to people.
In terms of making efforts to bridge the access gap, many CDMOs, including Windlas Biotech, have started their own trade generics business. Technology has played a significant role in bringing medicines close to customers. For instance, online aggregator apps like 1MG, PharmaEasy blend technology in healthcare to ensure faster and no-contact delivery. So, affordability and access are both improving, however, penetration of such initiatives might take a little bit longer, but the gap will definitely be bridged.
People generally prefer branded drugs over generics, so how does one build consumer trust. How are CDMOs helping build that trust?
A lot of trust that exists in the branded products comes from the efforts made by pharma companies. They’ve spent decades investing in research and development, training doctors and ensuring safety and efficacy of the drugs. However, the drug delivery landscape has evolved significantly in last couple of years. Today, customers have more than 20 options to choose from, when searching for a particular salt. So, the customers are beginning to weigh in pros and cons of buying a branded drug over a generic drug.
How can GMP for generic drugs be made more pronounced?
Generic drugs must be encouraged to reach all of India’s population; hence the quality of these drugs must be regulated. Titled as “Good Manufacturing Practices and Requirements of Premises, Plant and Equipment For Pharmaceutical Products”, the Schedule M is the standard for pharmaceutical products. The new Schedule M has seen several changes made to the previous one. The quality validation and GMP aspects have been strengthened a lot more in this new law. Additionally, CDMO companies are also reviewing their compliance to the new Schedule M and taking necessary steps to make investments wherever required in order to be more compliant.
In the long-term, the pressure to be compliant is good for the company and the patient. It would be helpful for the good players win; companies that are complying to the norms, making investments, hiring the right talent, and are growing in an orderly fashion. This will ultimately enhance patient safety. So, from a regulatory perspective, it’s a good, strong initiative. However, it all depends on enforcement.
Is there any alternative approach for generics for accessibility and affordability?
Outside generics, insurance is the only other option. Given the population and variances in population density among states in India, having insurance so easily available is not feasible. An initiative like Ayushman Bharat is a step in the right direction as it has been providing health insurance coverage for low-income earners in the country. This is extremely important for moving towards an independent India (Atma-nirbhar Bharat). In addition, when insurers prioritize generics over than branded drugs, then we push more towards accessibility and affordability of drugs in the country.
Today clinical trials have become a subject of debate when it comes to vaccine development, talking specifically with regards to your vertical, what is your perspective on the R&D and clinical trial?
Our areas of research currently include taking existing molecules, existing therapies and making them patient-centric. The kind of R&D we partake in involves making fixed dose combinations that comprises of controlled release, sustained release products, or some value addition in the generics where we make improvements for the user/ patient.
As per the New Drugs and Clinical Trial (NDCT) Rules, any changes made to the fixed dose combination or any change in the delivery pattern of the drug is considered as a new drug. For this the Drug Controller General of India (DCGI) has set up regulations, that everyone needs to follow. There are two types to this: 1) simple bioequivalent studies, and 2) clinical trial demonstrating efficacy, safety across the patient population. The clear understanding of these rules sets a good ground for companies to initiate innovative ideas. As a company we too have been investing and are also pursuing our set of innovative ideas in the therapeutic sector.